ES2333142T3 - SYSTEM FOR THE PLACEMENT OF A SURGICAL IMPLANT. - Google Patents

Abstract

An assembly for placing a surgical implant (1) having at least a portion (9, 11, 13, 15) of the implant extension, the assembly comprising: a guide element (52) having a distal end (62) for penetrate tissue; a cannula (54) having a proximal end (68), a distal end (70), and a channel (72) extending therethrough into which the guide member (52) can be inserted slidably , so that the tip (62) for penetrating tissue of the guide element (52) protrudes from the distal end (70) of the cannula (54); and a recovery device (56) having a capture element (62) at a distal end (64) thereof to engage with the extension portion (9, 11, 13, 15) of the surgical implant (1); in which the cannula (54), which has the guide element (52) slidably inserted therein, is sized to extend through the pelvic cavity of a patient from an external incision and exit through an incision vaginal, and the channel (72) of the cannula is sized to allow passage through it of the recovery device (56) and of the extension portion (9, 11, 13, 15) of the implant coupled thereto, and characterized in that the cannula (54) additionally includes a resilient end region (80), in which the resilient end region (80) adopts a first shape when the guide element (52) is inserted therein, and assumes a second shape when the guide element (52) is removed from the cannula (54), the second having a greater curvature than the first.

Description

System for implant placement surgical.

Field of the Invention

The present invention generally relates to systems for surgical implant placement, and has special application in implant placement for surgery pelvic floor reconstructive.

Description of the prior art

The use of synthetic and / or biological meshes in the surgical repair of damaged fascial tissues, such as hernias, has been described extensively in the literature and in the Patent filings Recently, the attention in the application of these materials and techniques for repair of defects in the female pelvic floor, such as cystocele, rectocele, enterocele and prolapse of the dome. Unfortunately, the surgical procedures developed to address these defects have not demonstrated the same levels of Constant clinical success as recognized areas of application surgical

It is believed that there are several factors that they contribute to the sub-optimal results seen in the field of pelvic floor repair. First, that the anatomy of the pelvic floor is complex and variable, particularly in the presence of fascial defects. The known surgical procedures they also require an extremely high level of skill surgical, since surgeons must often gain access to the pelvic cavity from a transvaginal approach. Additionally, many pelvic floor repair surgeries require cutting and dissecting very close to critical structures such as the bladder, rectum, peritoneum and a variety of significant nervous and vascular structures. Saturation deep inside the pelvic cavity is also difficult and requires time, and is often used due to the absence of others standardized repair procedures for clinical help. Finally, there is also a lack of instrumentation specifically designed for such surgical procedures, forcing the surgeons to use instruments designed for others procedures

Certain recent procedures have tried to address some of the concerns set forth above. U.S. Patent Publication No. 2003/0220538, describes a standardized procedure and an associated implant design that It is designed for use in various repair procedures of the pelvic floor. The procedure described eliminates the need of securing the implant with suture by providing strip type mesh extensions that pass through the ligament sacrospinous and / or obturator membrane. The Patent Publication American No. 2004/0039453 also describes a system of implant based on strips for the treatment of a cystocele. Without however difficulties have been encountered in recovering extensions Mesh through the pelvic cavity. In particular, being Recovered mesh extensions can cause tearing of the tissue, which can cause additional pain, bleeding, and / or damage to the nerves, but it can also lead to improper placement of the implant

Document US2003091373 (BERGER) describes a apparatus for treating female nervous urinary incontinence of according to the preamble of claim 1. The apparatus includes a pair of curved placement needles adapted to be inserted into the abdomen of a female, and be positioned in either side of the bladder neck to define a laying path for a tape. The tape can be fastened by detachable way to the placement needles that pass through the vagina to implant it in the abdomen to support the urethra.

The document US2003045892 (KALADELFOS) provides a surgical instrument to insert an element elongated in a human patient. The instrument has a hollow rod and curve that defines an arc corresponding to the general curvature of a passage between the anterior vaginal wall and the abdomen of a female patient and who has a sharp tip at one end and a handle on the other end. An elongated threader element is used to pass a filamentous element through the cane.

US5112344 (PETROS) describes a surgical instrument for the application of a filamentous element  in the body to treat female incontinence. The instrument it comprises a tubular rod that has a handle at one end and in the other end a flexible needle element that can be received in The cane slider mode. The cane is adapted to receive a filament.

Therefore, a Enhanced instrumentation specifically designed to facilitate, simplify and make more consistent the placement of implants in such procedures.

Objects and summary of the invention

The present invention provides a set for the placement of a surgical implant that has at least one implant extension portion. The set includes an item guide that has a distal end to penetrate the tissue, a cannula that has a proximal end, a distal end, and a canal that extends through it and whose interior can receive slidingly to the guide element, so that the tip of the guiding element to penetrate the tissue protrudes from the end distal of the cannula, and a recovery device that has a capture element at a distal end thereof to couple with the portion of the surgical implant. When the cannula has received by sliding the guide element, it is sized to extend through a patient's pelvic cavity from a external incision and exit through a vaginal incision, and the Cannula channel is sized to allow passage through thereof of the recovery device and the extension portion of the implant coupled to it.

A procedure is also described, which is not It is part of the invention, to place a surgical implant, which includes the steps of providing a set that includes a guide element having a distal end to penetrate the tissue, a cannula that has a proximal end, a distal end, and a channel that extends through it, and a device of recovery that has a capture element at a distal end of the same. The procedure additionally includes the steps of insert the guide element by sliding it into the cannula channel until the tip to penetrate the tissue protrudes from the end distal of the cannula, pass the cannula and the guide element through of a first step through the pelvic cavity of a patient from an external incision until the distal ends of the guide element and cannula come out through an incision vaginal, remove the guide element from the cannula by removing it to through the cannula channel, insert the device recovery through the cannula channel until the element capture out the distal end of the cannula, attach the capture element at a first extension of the implant to be placed, remove the recovery device and the extension portion of the implant, coupled thereto, back through the channel of the cannula so that the extension of the implant extends through the cannula, and remove the cannula to leave the extension of the implant in the first step.

The procedure may additionally include the repetition of the previous stages at the opposite end of the Patient's body to place a second extension of the implant. You can also additionally include the steps of inserting the guide element sliding it through the cannula channel until the tip to penetrate the tissue protrudes through the distal end of the cannula, pass the cannula and the guide element through a second step that crosses a patient's pelvic cavity from a second external incision until the distal end of the guiding element and cannula come out through the vaginal incision, remove the guide element from the cannula channel by removing it from through the cannula channel, insert the device recovery through the cannula channel until the element capture out the distal end of the cannula, attach the capture element to a second extension of the implant, remove the recovery device and the second extension of the implant, coupled to it, back through the cannula channel of so that the extension of the implant extends through the cannula, and remove the cannula to leave the second extension of the implant placed in the second step.

These and other objects, features and advantages of the present invention will become apparent from the detailed description of illustrative embodiments thereof, which It has to be read with respect to the attached drawings.

Brief description of the drawings

Figs. 1a-1c illustrate some exemplary meshes that can be placed using the system and the procedure of the present invention.

Fig. 2 illustrates the placement of a mesh specimen inside the body to treat a cystocele.

Fig. 3 illustrates the placement of a mesh specimen inside the body to treat both a cystocele and a rectocele.

Fig. 4 illustrates the placement of a mesh specimen inside the body to treat a rectocele.

Fig. 5 illustrates an exemplary guide element of the whole of the present invention.

Fig. 6 illustrates an exemplary cannula of the set of the present invention.

Figs. 6a and 6b illustrate, in section transverse, alternative exemplary configurations of the cannula of Fig. 6.

Fig. 7 illustrates a recovery element copy of the set of the present invention.

Fig. 8 illustrates the cannula of Fig. 6 inserted in the guide element of Fig. 5.

Figs. 9a-9d illustrate, in cross section, various alternative configurations for the recovery element of Fig. 7.

Figs. 10a-10d illustrate various configurations of an element capturing an element of recovery of the present invention.

Fig. 11 illustrates a recovery element according to the present invention including an element of capture that has a preformed curve.

Figs. 12a-12f illustrate various stages of a procedure to place an implant surgical according to the present invention.

Detailed description of the preferred embodiments

Although the present invention is described with detail in relation to particular implants to treat defects of the pelvic floor, it should be understood that the invention is not so limited, since there are many other types and configurations of implants that can be placed using the sets described here, and defined by the appended claims.

Figures 1a-1c illustrate exemplary implants for use in a pelvic floor repair that can be placed using sets and procedures described here. Figure 1a illustrates a mesh suitable for use in a previous repair or cystocele. The central portion 3 of the Implant 1 is designed to be placed under a low tension or void between the patient's urinary bladder 5 and vagina 7, to thus reinforce the fascia between the two and prevent the bladder from pushing the vagina down, as illustrated in Fig. 2. The Implant 1 includes a first set of extensions 9, 11 strip type of the implant and a second set of extensions 13, 15 strip type implant that extend outward from opposite sides of the implant. As shown in Figs. 2 and 3, both games of extensions 9, 11; 13, 15 type implant strip are designed to pass from a location near the tendon arc of the pelvic fascia (ATFP) 17, through the obturator membrane and leave the body through the shutter foramen 19. The passage of implant extensions through the tissue along the steps described above anchor the implant in place by friction medium and finally tissue growth on the implant.

An exemplary implant is shown in Fig. 1b to treat an apical, posterior / rectocele repair. He implant 20 includes a central portion 22 that is designed to be placed under a low or zero tension between rectum 27 and the patient's vagina 7 (as shown in Fig. 4), reinforcing the fascia between them and preventing the rectum from pushing the Vagina up. The implant 20 includes two extensions 24, 25 of the strip implant that extend outwardly therefrom in opposite directions. These implant extensions are designed to extend through the sacrospinous ligaments 29 of the patient and to leave the body through the gluteus muscle near the anus as shown in Fig. 3.

Fig. 1c illustrates an implant that is suitable for both the previous and subsequent repair when implants as shown in Fig. 3. Each portion of the implant combined, the anterior portion 30 and the posterior portion 32, is substantially similar to that described above for implants separated. A suitable material for the described implants formerly is Gynecare's GYNEMESH? PS, which is a woven polypropylene mesh that is 0.7 millimeters thick approximately and which is manufactured by Ethicon, Inc, of Somerville, New Jersey. This material is approved by the FDA at the United States for implantation in the human body to various uses

As described above, there are difficulties in trying to place implants on the pelvic floor, and the present invention provides a set and a method improved to do it. The set consists of the components shown in Figs. 5-7, and includes an item 52 guide, a cannula 54, and a recovery element 56. He guide element includes a handle 58 that has any proper configuration to grab and manipulate the element of guide, and a needle 60. The needle includes a distal tip 62 of tissue dissection, which is preferably blunt but conical, and preferably additionally includes a first portion 66 substantially straight extending from the handle, a portion curved transition 64 extending from the first portion substantially straight, and a second portion 67 substantially straight line that extends between the curved transition portion and the distal tip 62. In a preferred embodiment, the length of the first substantially straight portion is approximately 75 mm, the length of the second substantially straight portion is 10.6 mm approximately, and the length of the curved portion is 111 mm approximately. Additionally, dimensions a and b shown in Fig. 5 they are approximately 73 and 168 mm respectively, and The diameter of the needle is between 3 and 5 mm.

The needle must be substantially rigid to that can resist deformation under the forces that they usually experience passing the needle through the body such As described here. Some materials suitable for this purpose are various alloys of stainless steel or titanium.

Suitable materials for the handle include steel, aluminum, titanium, plastic, rubber, etc. In the case of a plastic handle, any manufacturing process can be used standard for forming, such as shaping the handle by insertion of the needle, mold the handle in two halves and snap them together or use ultrasonic welding to connect the two pieces of the handle around the needle, etc.

Cannula 54 is shown in Fig. 6 and consists preferably in a flexible or semi-rigid material and has a proximal end 68, a distal end 70 and a channel 72 that is extends through it between the proximal and distal ends. There may be a larger 74 cube portion at the end. proximal, and may have one or more projections 76 that extend out from it. The cube and projections allow the surgeon better cannula management and prevent the cannula from insert too much into the patient as described in more detail later. Projections can also be designed so that they secure the cannula in place within the surrounding tissue. The cannula and the guide element are mutually sized so that the needle 60 of the guide element can slide through channel 72 of the cannula as it shown in Fig. 8, with the tip 62 to penetrate the tissue of the guide element 52 protruding from the distal end of the cannula The distal end 70 of the cannula is preferably tapered for a smooth transition between tip 62 to penetrate the tissue of the guide element and the circumference outside 78 of the cannula, as shown in Fig. 8. Of this way, during insertion of the cannula and the guide element it Minimizes trauma to surrounding tissue. Additionally, the diameter of the distal end of the cannula canal is preferably slightly smaller than the rest of the channel, and even slightly smaller than the diameter of the guide wire of so that with the insertion of the needle it dilates to form a tight fit between the guide wire and the cannula. This can achieved by reducing the diameter of the canal at the distal end by secondary operations, or by adding a Second material after manufacturing.

In a preferred embodiment, the cannula includes additionally a resilient final region 80 comprising a resilient and flexible enough material so that at insert the guide element into the cannula, the cannula adopt the configuration of the guide element as shown in Fig. 8. However, when the guide element is removed, the final region 80 resilient returns to a configuration that is different and more curved than that of the corresponding portion of the guide wire, as shown in Fig. 6. This aspect is important for help the recovery element step, as well as will explain in greater detail later. This feature can achieved by exposing the cannula to heat either before or after its formation, or simply by mechanical manipulation of the cannula such as placing it on a reel of a desired curvature. In a embodiment, the length of the hub portion 74 is 18 mm approximately, the length of the substantially straight portion is approximately 155 mm, the length m 3 of the region Resilient finish is approximately 35 mm with an angle A of 80 degrees approximately, and the length of the final region including The distal end is approximately 5 mm.

The cannula is preferably composed of PEBAX?, Which is a mixture of polyether and nylon, but can include, or be constructed with other diverse materials such as polyethylene, Teflon, PVDF, PFE and Pebax. Other ones can also be used. polymeric or non-polymeric materials, with low coefficients of friction, to bathe the interior and / or exterior surfaces of the cannula to reduce friction between the cannula and the guide wire and / or the tissue. This material can be reinforced with a spiral of wire, a plastic spiral, or a braid to increase the stiffness or provide resistance to curling. The cube can be composed of a different material, such as foam, but also it could be any hard or soft plastic, or a material elastomeric such as urethane, rubber or silicone.

Additionally, both the guide wire and the cannula can include a mark, protrusion or other feature 71a, 71b that are aligned with each other when the cannula is properly inserted and oriented with respect to the needle of guide as shown in Fig. 8. In one embodiment alternatively, the assembly may include a means for coupling mechanically the cannula and the guide wire, such as a groove or a notch in the needle or handle that matches an element Corresponding cannula. Other features that may be added include one or more radiopaque marks to allow viewing after placement using fluoroscopy or x-rays, or the addition of spaced 73 marks regularly throughout the cannula so that the user can determine how far the cannula has been inserted into the body of the patient, and also to determine if the position of the cannula has changed after initial placement.

The cannula preferably has a section substantially circular cross section with a single channel through the same as shown in Fig. 6a, but may have any other suitable configuration in cross section. Alternatively you can have two or more lumens, with a lumen providing step for the guide wire and a second providing the passage of the recovery line.

The final element of the set is the line of recovery, shown in Fig. 7. In its most basic form, the recovery element 56 is a flexible elongated instrument or semi rigid which has a capture element 62 at the end distal 64 that is suitable for capturing or securing a portion of an implant extension of the mesh to be implanted. He recovery element is sized so that it can be dragged (and the portion of a mesh implant extension) through the cannula channel as will be described more ahead. As shown in Fig. 7, in one embodiment preferred, the capture element is a simple loop across the that the portion of an implant extension can be inserted to that can be dragged through the cannula channel. Too you can imagine many other configurations for this element capture, such as spike elements, various staples, cinch or loop mechanisms, etc., several of which are shown in Figs. 10a-d.

The recovery line can be made of any suitable material that has sufficient rigidity to that can be introduced through the cannula and to a point exterior in which it is easily accessible to the surgeon. A Suitable material is a polypropylene material such as PROLENE® (manufactured by Ethicon, Inc.) but others are also suitable many semi-rigid plastics, such as acetal, ethylene tetrafluoroethylene, fluorinated ethylene propylene, high polyethylene or low density, nylon, polycarbonate, or polyurethane. Additionally, stainless steel or nitinol are also adequate.

In one embodiment, the recovery element it is a simple monofilament extrusion that has a section substantially circular cross section as shown in Fig. 9a. In alternative embodiments, the recovery element it could be a tubular extrusion, an extrusion with lumens multiple (Fig. 9b), a spiral wire similar to a wire of stainless steel catheter guide, a braided configuration of plastic or stainless steel lines (Fig. 9c), or an extrusion with one or multiple lumens that have any form of section cross section that is not substantially circular (Fig. 9d). Too one or more of the above could be combined, for example to create a plastic coated wire, a tube reinforced with Mesh (with braided metal or plastic mesh), or dual extrusions With different plastics in different layers of extrusion.

A preferred embodiment of the element of recovery is further illustrated in Fig. 10a, and includes  a thermo-retracted plastic tube 90 on a loop 92 of monofilament, as described above. In alternative constructions, however, the monofilament can just bend over yourself to form the loop and then weld together, or monofilament 94 can be inserted through a double lumen extrusion 96 (i.e., Fig. 10b). Such as indicated above, the recovery element may alternatively include any suitable form of mechanism 98 webbing or mechanical capture mechanism 99 such as illustrated in Figs. 10d and 10c respectively.

Finally, the recovery element too It can include various features to make its use easier to the surgeon For example, the recovery line may include a curve 101 preformed at its distal end (Fig. 11), which is designed to point the recovery line in the most direction easily accessible to the surgeon after he has advanced through the cannula channel and out of the incision vaginal. You can also include various features in your proximal end, such as gradual marks to indicate the degree of insertion, or features in the handle such as ties, balls, etc. to facilitate grip and end grip proximal recovery line.

In an alternative embodiment, the cannula could be a two-channel cannula that has such a cross section as shown in Fig. 6b. The first channel 81 would be sized to receive the guide wire as described previously, and the second channel 82 would be sized to Receive the recovery line.

Some of the following will be described in detail preferred procedures, which are not part of the invention, for the use of the surgical assembly of the present invention. This procedure will be described with respect to the insertion of a mesh such as that shown in Fig. 1a to repair a cestocele, but it should be understood that this is only illustrative, since that the set described here can be used to place various types and configurations of meshes to repair other defects various of the pelvic floor, or to perfect other conditions various doctors. Additionally, the procedures described here they are exemplary, and other meshes of different types can be placed ways and through different steps using the set of the present invention

In preparation for implant insertion of Fig. 1a, the entire thickness of the anterior vaginal wall is cut as necessary and adequate lateral dissection is performed associated. The skin incision for the passage of extension 13 of the mesh is made in the skin that covers the anteromedial part of the obturator foramen, at the level of the urinary meatus. This incision it should be approximately 4 mm long that element 52 of guide and cannula 54 can pass through the skin without tearing it. The cannula 54 is inserted, or has been previously inserted, on the guide needle 52 as shown in fig. 12th until the tip to penetrate the tissue protrudes from the distal end of the cannula as shown in Fig. 8. Then the cannula and the guide element through the incision, through the obturator membrane, and are directed by a relatively path directly so that at the tip it exits through the space previously dissected at the appropriate location as shown in the Fig. 2. Once the distal tip of the guide element and the cannula come out through vaginal dissection, the guide element is removed of the cannula as shown in Fig. 12b, leaving the cannula placed on the body.

To pass the extension 9 of the implant, it is done a second skin incision at the level of the urinary meatus, approximately 3-4 cm below the incision precedent in the inferomedial part of the obturator foramen. So the guide element and the cannula are inserted through the skin, to through the obturator membrane along a route that allows them emerge from the ileococcigeus muscle behind the ATFP, approximately 1-1.5 cm from the hamstring at the bottom of the paravesical fossa. Then, the recovery elements through each of the cannulas placed, one by one as shown in Fig. 12c, until the capture element exits through the vaginal incision as it is shown in Fig. 12d. Then the surgeon grabs the element of capture, retrieve it out of the vagina, and pass extension 13 of the implant through the capture element as shown in Fig. 12e, in order to ensure or detachably attach the Implant with recovery line. Then the line is removed of recovery, and the extension of the implant coupled to it, back through the cannula channel until the end of the extension of the implant comes out from the proximal end of the cannula as shown in Fig. 12f. Once all the strips passes are out of the body, final adjustments are made. Subsequently, the cannulas are removed from the body, leaving the implant extensions extended through the steps previously occupied by the cannulas. Then the Implant extensions near the incisions. The tissue that surrounding the implant extensions will basically collapse on implant extensions, securing them in place and leading to its growth inside them.

Then these steps are repeated on the side opposite of the body to pass the extensions 15, 11 of the implant. Then the implant extensions are trimmed very close to the incisions in the upper leg and / or the lower part of the abdomen

To place the posterior implant of Fig. 1b, the surgeon first makes a full thickness incision of the posterior vaginal wall and an appropriate lateral dissection to expose the sacrospinous ligament. Then some incisions are made on the skin of the buttocks laterally and below the anus and it insert in these incisions a guide loaded by cannula, leaving through the sacrospinous ligament 2 cm from the ischial spine approximately. Then the guide is removed and installed and used a recovery line as described above for the previous implant. As with the previous implant, These operations are carried out on both sides of the patient.

As indicated above, the line of recovery can include a preformed curve 101 (Fig. 11) in the distal end This preformed curve makes the surgeon easier to access the recovery line once it has come out by the vaginal incision, since the curve can be configured so that extend from the incision in a direction towards the surgeon. Similarly; the resilient end region 80 of the cannula can be configured so that, after removal of the guide wire, the end resilient region return to a more curved configuration (it is say, Fig. 6) pointing in a direction that facilitates the surgeon pass the recovery line.

Although embodiments have been described here illustrative of the present invention with reference to the drawings attached, it should be understood that the invention is not limited to those precise embodiments, and that one skilled in the art can make other various changes and modifications thereof without move away from the scope of the invention, as set forth in the attached claims.

Claims (13)

1. A set to place an implant surgical (1) that has at least a portion (9, 11, 13, 15) of Implant extension, comprising the set: a guide element (52) having an end distal (62) to penetrate tissue; a cannula (54) having a proximal end (68), a distal end (70), and a channel (72) extending to through it into which the element of guide (52) slidably, so that the tip (62) stops penetrate tissue of the guide element (52) protrudes from the distal end (70) of the cannula (54); Y a recovery device (56) that has a capture element (62) at a distal end (64) thereof for couple with the extension portion (9, 11, 13, 15) of the implant surgical (1); in which the cannula (54), which has the guide element (52) slidably inserted therein, is sized to extend through the pelvic cavity of a patient from an external incision and exit through an incision vaginal, and the channel (72) of the cannula is sized to allow passage through it of the recovery device (56) and of the extension portion (9, 11, 13, 15) of the implant coupled thereto, and characterized because the cannula (54) additionally includes a region resilient end (80), in which the final resilient region (80) takes a first form when the guide element (52) is introduced inside, and assumes a second form when the guide element (52) is extracted from the cannula (54), having the second forms a greater curvature than the first. 2. The assembly according to claim 1, in which when the guide element (52) is inserted inside the cannula (72), the guide element and the cannula (54) are sized to form a substantially smooth transition from the distal end (62) to penetrate tissue of the element of guide to an outer surface of the cannula (78). 3. The assembly according to claim 1, in which the proximal portion of the cannula (68) includes additionally a larger cube portion (74). 4. The assembly according to claim 3, in which the hub portion (74) additionally includes a plurality of projections (76) extending outwardly from the same. 5. The assembly according to claim 3, in which the hub portion (74) additionally includes a clamping and recovery element to fit Detachable the recovery element (56) to the cannula. 6. The assembly according to claim 1, in which the distal end (64) of the recovery element (56) includes a preformed curve (101). 7. The assembly according to claim 1, in which the capture element is a loop (92). 8. The assembly according to claim 1, in which the capture element is a hook. 9. The assembly according to claim 1, in which the surgical implant (1) is a mesh for pelvic floor repair. 10. The assembly according to claim 9, in which the surgical implant (1, 30) is a mesh for cystocele repair. 11. The assembly according to claim 9, in which the surgical implant (20, 30) is a mesh for rectocele repair. 12. The assembly according to claim 1, in which the external incision is an incision in the part lower abdomen. 13. The assembly according to claim 1, in which the external incision is an incision in the part upper leg near the obturator foramen.